Kornimate/medical-research-clean huggingface dataset:
irradiation of melanoma in a pulse

Conditions: Metastasis From Malignant Melanoma of Skin (Diagnosis)

Summary: this is a single center phase i, first-in-human, dose escalation study of flash therapy in patients with metastases of melanoma. the trial is based on escalating single doses of flash therapy administered to skin melanoma metastases using the mobetron® with high dose rate (hdr) functionality. the aim of the study is to evaluate a dose escalation of high dose rate radiotherapy (flash therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments. melanoma is a typically radio-resistant tumor type, which can justify such a dose escalation with a new type of radiotherapy that appears much better tolerated than conventional radiotherapy.


Eligibility criteria:
inclusion criteria: 1. signed study informed consent form 2. karnofsky performance status (kps) ≥ 50 3. age ≥ 18 years 4. patients with metastatic melanoma and multiple skin metastases with a documented clinical progression despite the systemic treatments (chemotherapy, and/or programmed cell death 1 (pd1), cytotoxic t-lymphocyte antigen-4 (ctla4) inhibitors or tyrosine kinase inhibitors (tkis), such as v-raf murine sarcoma viral oncogene homolog b1 (braf) or mitogen-activated extracellular signal-regulated kinase (mek) inhibitors) 5. the size of the treated lesions should be ≤ 5.5 cm in diameter and ≤ 2.8 cm thick (caliper-based measurement) 6. the treated lesions should be at least 5 cm apart and must not be located on the face. 7. women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (urine or serum) during screening 8. wocbp must use a contraceptive method exclusion criteria: 1. previous radiotherapy in the treated area 2. concomitant auto-immune disease with skin lesions 3. concomitant use of radio-sensitizer drug 4. women who are pregnant 5. current, recent (within 10 days prior start of study treatment), or planned participation in an experimental drug study. during the 4 weeks dlt period, the patient will not be able to participate to any other clinical study. 6. any serious underlying medical condition that could interfere with study treatment and potential adverse events 7. any mental or other impairment that may compromise compliance with the requirements of the study

Keywords: flash therapy melanoma
a study of the efficacy and safety of etrolizumab in participants with ulcerative colitis who have been previously exposed to tumor necrosis factor (tnf) inhibitors

Conditions: Ulcerative Colitis

Summary: this phase iii, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (uc) who have been previously exposed to tnf inhibitors.


Eligibility criteria:
inclusion criteria: * diagnosis of uc established at least 3 months prior to day 1 * moderately to severely active uc as determined by the mayo clinic score (mcs) assessment * treatment within 5 years prior to screening with one or two induction regimens that contain tnf inhibitors (including tnf inhibitor biosimilars) * washout of anti-tnf therapy for at least 8 weeks preceding day 1 * background regimen for uc may include oral 5-aminosalicylic acid (5-asa), oral corticosteroids, budesonide, probiotics, azathioprine (aza), 6-mercaptopurine (6-mp), or methotrexate (mtx) if doses have been stable during the screening period * use of highly effective contraception as defined by the protocol * must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening exclusion criteria: * a history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps * prior or planned surgery for uc * past or present ileostomy or colostomy * any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) * any prior treatment with anti-adhesion molecules (e.g. anti-madcam-1) * any prior treatment with rituximab * any treatment with tofacitinib during screening * congenital or acquired immune deficiency, chronic hepatitis b or c infection, human immunodeficiency virus (hiv) positive, or history of tuberculosis (active or latent) * evidence of or treatment for clostridium difficile or clinically significant cytomegalovirus (cmv) colitis within 60 days prior to day 1 * evidence of or treatment for other intestinal pathogens within 30 days prior to day 1 * history of recurrent opportunistic infections and/or severe disseminated viral infections * history of organ transplant * any major episode of infection requiring treatment with intravenous (iv) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening * received a live attenuated vaccine within 4 weeks prior to day 1
study of fibrinogen metabolism during severe trauma and burns

Conditions: Burn Injury; Major Trauma

Summary: to study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. as a result of the burn or trauma injury breakdown of fibrinogen is accelerated.

in this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13c-phenylalanine, 2h5-phenylalanine, and 2h3-ketoisocaporate). the increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by gc-ms) will be used to calculate fibrinogen synthesis and degradation. stable isotopes are non-radioactive.

Eligibility criteria:
inclusion criteria: * 20% total body surface area burn or more * severe trauma with injury severity score greater than 10 * between ages of 18 and 65 years exclusion criteria: * history of blood clotting disorder * history of liver disease such as cirrhosis or hepatitis * pregnant or nursing * allergic to iodine, shellfish or dye used in x-rays * taking long term medications for blood clotting usch as coumadin or plavix * prisoners * receiving total parenteral nutrition

Keywords: fibrinogen burns trauma metabolism
depression and immune function in multiple sclerosis (ms)

Conditions: Multiple Sclerosis; Depressive Disorder, Major

Summary: depression is one of the most common symptoms of multiple sclerosis (ms) with a life-time prevalence of major depressive disorder (mdd) of up to 50%. depression occurs more frequently in ms than in other chronic diseases including other neurological and inflammatory disorders and may contribute to lower quality of life, cognitive problems, difficulties at work, and poorer long term health outcomes. despite its clinical relevance, the biological mechanisms which may be responsible for the high risk for ms patients to develop depression are unknown. in this observational study, investigators explore the molecular mechanisms responsible for the impaired regulation of immune cells in relapsing-remitting (rr) ms patients with depression. investigators will compare the molecular and phenotypical profile of immune cells obtained from rrms patients with clinical depression (n=50), matched ms patients who do not suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients with depression but without a comorbid neurological disorder (n=50).


Eligibility criteria:
inclusion criteria: * relapsing remitting ms by mcdonald criteria (for rrms and rrms+mdd groups). * currently meeting diagnostic criteria for major depressive disorder (for mdd and rrms+mdd groups) * age 18-55. * on stable treatment regime, either untreated or on disease modifying therapy (dmt) for \> 6 months exclusion criteria: * secondary-progressive or primary progressive ms. * substance abuse for more than 6 months. * pregnancy * use of steroids or vaccination or infections in the previous 3 months. * signs of serious psychiatric pathology other than depression including schizophrenia, bipolar disorder or developmental and learning disorders including disorders on the autism spectrum * antidepressant medication.
narrow-band imaging (nbi) versus lugol chromoendoscopy in the detection of oesophagus squamous cell carcinoma in high risk population

Conditions: FRENCH STUDY

Summary: narrow-band imaging (nbi) is as sensitive as lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (scc) and appears more specific than lugol chromoendoscopy in expert centres but its specificity in current practice is not known. this study aimed to prove the superiority of nbi specificity over lugol chromoendoscopy to detect oesophageal scc and high-grade dysplasia (hgd) in current practice (including tertiary care centres, local hospitals and private clinics).


Eligibility criteria:
inclusion criteria: * patients had a history or current scc exclusion criteria: * none
management of post-tonsillectomy pain in pediatric patients

Conditions: Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis

Summary: single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.


Eligibility criteria:
inclusion criteria: * 4 to 17 years of age at time of enrollment * undergoing tonsillectomy with or without adenoidectomy * able to provide informed consent from parent or legal guardian * able to provide assent if subject is a minor of appropriate age exclusion criteria: * allergy to acetaminophen or ibuprofen * inability for study participant to cooperate with pain assessments * known pregnancy * any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
efficacy of gzr/ebr in early chronic hepatitis c in hiv/hcv co-infected patients

Conditions: Hepatitis C; HIV

Summary: evaluate the efficacy of 12 or 8 weeks treatment with grazoprevir/elbasvir in early chronic hepatitis c gt1,4 in hiv co-infected patients and evaluate the safety and tolerability of grazoprevir + elbasvir in hiv-hcv co-infected patients.

genotype 1b: 8 weeks treatment with grazoprevir/elbasvir genotype 1a and 4: 12 weeks treatment with grazoprevir/elbasvir

Eligibility criteria:
inclusion criteria: * ≥18 years of age * patients with early chronic hepatitis c (genotype 1 or 4) which is defined as chronic hepatitis c with known episode of ahc within the last 4 years including those who failed to peg/rbv or those who never received therapy for ahc. ahc infection is diagnosed on the basis of documented hcv-rna positivity (\> 10.000 iu/ml) and anti-hcv seroconversion. * no history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease * have liver disease staging assessment as follows: fibroscan performed within 3 previous months of day 1 of this study showing result \<8 kpa * be hiv-1 infected, documented by any licensed rapid hiv test and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid hiv and/or e/cia, or by hiv-1 p24 antigen, or plasma hiv-1 rna viral load. * be on stable hiv antiretroviral therapy (art) for at least 8 weeks prior to study entry using a dual nrti backbone of tenofovir or abacavir exclusion criteria: * \< 18 years of age * patients with chronic hepatitis c genotypes other than 1 or 4. * history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease * have liver disease staging assessment as follows: fibroscan performed within 3 previous months of day 1 of this study showing result \> 8kpa * not be hiv-1 infected, documented by any licensed rapid hiv test and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid hiv and/or e/cia, or by hiv-1 p24 antigen, or plasma hiv-1 rna viral load. * due to known or suspected drug-drug interactions, for the purpose of this study, the use of non nucleoside reverse transcriptase inhibitors, inhibitors or protease inhibitors against hiv will be not allow.
fitting non-invasive tests in lynch syndrome surveillance

Conditions: Colorectal Cancer

Summary: the purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (fit) in comparison to colonoscopy in patients with lynch syndrome (ls) who are undergoing colonoscopy surveillance.

lynch syndrome (ls), the most common inherited cause of colorectal cancer (crc) affecting about 1.2 million americans. colonoscopy starting early in adulthood and repeated yearly or biennially is the only recommended surveillance strategy which translates into about 25-50 lifetime colonoscopies. this intensive colonoscopy surveillance is not ideal because crc risk varies widely by ls gene and age, colonoscopies are invasive, costly, and not readily accessible to all patients, and adherence is suboptimal. this clinical study will examine the performance of the fecal immunochemical test (fit) in lynch syndrome (ls) patients undergoing colonoscopy surveillance. in addition to assessing the characteristics of the fit test, such as specificity, sensitivity, and both negative and positive predictive values, the study will also explore ls patients' attitudes toward and acceptability of non-invasive testing methods. this comprehensive approach aims to provide insights into both the diagnostic effectiveness of fit and the potential for improving patient adherence to screening protocols through less invasive options.

Eligibility criteria:
inclusion criteria: * have a diagnosis of ls with a confirmed pathogenic variant in mlh1, msh2, msh6, pms2 or epcam genes. * aged 20 - 75 years * have an upcoming standard of care (soc) colonoscopy appointment in line with standard ls surveillance guidelines (nccn). * willing to sign informed consent, collect stools samples and complete surveys exclusion criteria: * individuals who have not proceeded with genetic testing and therefore are not known to have ls, despite family history and/or criteria for testing. * individuals who have previously undergone a subtotal or total colectomy. * newly diagnosed lynch syndrome patients \< 20 years old with a pathogenic variant in mlh1, msh2 or epcam, msh6 or pms2. * individuals who are pregnant. * individuals with inflammatory bowel disease or active malignancy. * individuals not willing or able to sign informed consent.

Keywords: lynch syndrome colorectal cancer
paediatric autism communication therapy (pact) in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: paediatric autism communication therapy (pact) is a naturalistic developmental behavioural interventions to reduce autism symptoms. the aim of this trial is to assess the beneficial and harmful effects of pact in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.

autism spectrum disorder (asd) is a neurodevelopmental disorder affecting approximately 2% of children and young people worldwide. asd is considered a lifelong disorder and interventions significantly reducing the core autistic symptoms have been sparse. paediatric autism communication therapy (pact) is among the first naturalistic developmental behavioural interventions to show promising results for reduction in autism symptoms. the aim of this trial is to assess the beneficial and harmful effects of pact in 2-6 year-old children with a recent diagnosis of asd. this trial is an investigator-initiated, independently funded, pragmatic, national, parallel group, superiority, randomised clinical trial comparing pact combined with management as usual to management as usual alone.

Eligibility criteria:
inclusion criteria: * children aged 2 through 6 years (both inclusive) * a diagnosis of asd meeting the criteria for international classification of diseases; tenth edition (icd-10): diagnose codes: df84.0, df84.1, df84.5, df84.8 * an autism diagnostic observation schedule, 2nd edition calibrated severity score (ados-2 css) ≥ 4 * the asd diagnosis must be verified by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), autism spectrum disorder checklist * the asd diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference * parents must have sufficient danish (or english) language skills to communicate with the therapist * signed informed consent by parents or holders of legal guardianship exclusion criteria: * children having a sibling already included in the trial * hearing and visual impairment in child or parent * parent not available for regular sessions with the therapist, evaluated at the consent meeting
effectiveness of foot exercise people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Peripheral Neuropathy

Summary: the aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. subjects will be randomly allocated to either the control or intervention group. data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. the intervention and control groups will be examined and measured at the 4th and 8th weeks.

purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy. excepted results: routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, leeds assessment of neuropathic symptoms and signs(lanss) results. in this context, it is planned that patients randomly divided into 2 groups. group 1 control group. group 2 intervention group. patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. the patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.

Eligibility criteria:
inclusion criteria: * having type 2 diabetes mellitus for 5 years * hba1c \> among of between 6.5-10 * having grade 0 or 1 phase of wagner classification * diabetic neuropathy score ≥ 3 exclusion criteria: * not to know turkish * having hearing, visual and speaking problems * having (except diabetic neuropathy) other neurologic problems * having psychiatric and cognitive problems * having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise

Keywords: foot exercise pain
evaluation of effectiveness and safety of rotational atherectomy in routine clinical practice

Conditions: Atherosclerosis, Coronary; Coronary Stenosis

Summary: this study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * patients who received rotational atherectomy * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * life expectancy \<1y

Keywords: rotational atherectomy
to assess the effect of naproxcinod versus naproxen and ibuprofen on arterial blood pressure in osteoarthritis patients with controlled essential hypertension

Conditions: Osteoarthritis; Hypertension

Summary: to assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension

this is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. patients will be randomly allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.

Eligibility criteria:
inclusion criteria: * men/women, 40 or older, diagnosed with hip or knee osteoarthritis. * hypertensive patient with treated and controlled essential hypertension. * must receive at least one antihypertensive treatment from the following drug classes: diuretic, angiotensin-converting enzyme (ace) inhibitor, angiotensin receptor blockers (arb) or beta-blocker (bb). * must be current chronic user of nsaids or acetaminophen. * must discontinue all analgesic therapy at screening. exclusion criteria: * more than two different classes of antihypertensive drugs. * uncontrolled diabetes. * hepatic or renal impairment. * a history of alcohol/drug abuse. * diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding. * history of congestive heart failure. * clinically relevant abnormal ecg. * current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk. * current or expected use of anticoagulants. * participation within 30 days prior to pre-screening in another investigational study.
the effect of inspiratory muscle training on postural stability, posture perception and trunk rotation in children with adolescent idiopathic scoliosis.

Conditions: Adolescent Scoliosis

Summary: trunk rotation and distortion of the rib cage, which are common in patients with adolescent idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal muscles. this reduces the capacity of the respiratory muscles to produce force, and results in respiratory muscle weakness. the diaphragm, which is the major respiratory muscle, is also a component of the core muscles responsible for postural stability. therefore, diaphragm muscle weakness results in deterioration of postural stability. our aim in this study is to investigate the effect of inspiratory muscle training added to the routine scoliosis exercise program on postural stability and posture perception.


Eligibility criteria:
inclusion criteria: * having adolescent idiopathic scoliosis with a cobb angle of 20-50° diagnosed by an orthopedic surgeon exclusion criteria: * having a documented diagnosis of neurological disorders * having a documented diagnosis of mental disorders which may affect cooperation * having a documented diagnosis of chronic airway diseases * having a documented diagnosis of orthopedic disorders which may affect mobility

Keywords: postural stability posture perception inspiratory muscle training adolescent idiopathic scoliosis